HypertensionNCT03404999
Clinical-Decision Support to Improve Hypertension Care in Primary Care
A study testing clinical decision support in people with Hypertension and Blood Pressure, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Hypertension, Blood Pressure, Overweight and Obesity
- What is being tested?
- clinical decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,803 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Measured systolic or diastolic blood pressure >=90th % for age/sex, or
- >=120 mmHg systolic or >=80 mmHg diastolic (whichever is lower)
Who cannot join
- Lack of electronic health record
- Diagnosis/visit for high blood pressure or hypertension in past 2 years
- Taking anti-hypertensive medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)
Dallas, Texas, 75390
About this study
Official title: Automated Clinical-Decision Support to Improve Hypertension Care Among Overweight Children in Primary Care
Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. If successful, this approach can be used to address other lifestyle-related and complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used nationwide.
The investigators have developed a new, electronic health-record (EHR)-based tool that is designed to help pediatricians:
Read more
- IDENTIFY AND DOCUMENT
- when a child's blood pressure is elevated, and
- whether it has been elevated before--including number of prior elevations to document the correct diagnosis (for example, elevated blood pressure, vs. hypertension stage 1, vs. hypertension stage 2), THEN
- ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including:
- laboratories and studies per 2017 updated guidelines
- follow-up interval in primary care
- referral to nephrology, when indicated, and
- patient education on diet/lifestyle modification.
The investigators are working on improving this system further with addition of orders for:
- referral for sleep-apnea testing and treatment, when indicated, and
- blood-pressure medications (for example, initiation, titration, or addition of agents depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for pregnancy)
Read the detailed description
The investigators' data suggest that (1) addressing obesity-related comorbidities (in combination with high BMI/overweight/obesity) and more frequent follow-up are associated with weight-status improvement in overweight (OW) children, (2) that parents rank checking for weight-related health problems as the #1 most important recommended weight-management clinical practice, but that (3) comorbidities are infrequently addressed. Thus, to improve weight status, interventions are needed to improve comorbidity identification, evaluation, and management in primary care. Because the investigators' data suggest that identification of high blood pressure is particularly poor, and that identifying blood-pressure elevations in young children at three separate encounters is complex, they are using existing underutilized data to automate addressing high blood pressure/hypertension in an electronic health record system (EPIC-based), and, if successful, applying the method to other obesity-related comorbidities in primary care.
OF NOTE: in developing and pilot-testing this decision support tool, providers wanted access to it for patients without overweight/obesity. Thus, although the trial was borne out of work in weight-management research, the initial trial will focus on all children irrespective of weight status.
- Conditions
- Hypertension, Blood Pressure, Overweight and Obesity
- Being tested
- clinical decision support
- Medical subject headings
- Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical decision supportOther
Decision support system (see description of hypertension decision support system alerts and order sets for details)
| Study group | Role | What they receive |
|---|---|---|
| clinical decision support activated | Experimental | TWO MED ASSIST ALERTS
1. Enter height (when missing)
2. Repeat BP (when high)
ONE PROVIDER ALERT
1. BP high \& prior BP/BP%s
2. Defines elev. BP, HTN stage 1-2 with button to enter diagnosis
3. Link to tailored ordersets
TAILORED ORDERSETS
1. Elevated BP
1. Button to schedule f-up <6 m
2. Button for diet/lifestyle counseling/check-out instructions
2. HTN stage 1
1. Buttons to order labs/studies pre-checked for stage 1 recs
2. Button for nephrology referral
3. Button to schedule f-up in 1-2 wk/<1 m
4. Button for diet/lifestyle counseling/check-out instructions
3. HTN stage 2
1. Buttons to order labs/studies for stage 2
2. Button for nephrology referral (pre-checked)
3. Button to f-up 1 wk
4. Button for diet/lifestyle counseling/check-out instruction Receives: Other: clinical decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
High blood pressure addressed
Proportion of patients with high blood pressure addressed post decision-support implementation (vs. pre-), defined as proportion of patients with elevated blood pressures or higher who have one or more diagnosis or orders placed to diagnose, evaluate, or manage hypertension. We will compare the slope of the post- vs. pre-implementation periods to examine change in monthly rate of HTN eval/management (indicated elements ordered/patients eligible) related to decision support that are in excess of secular trends in clinical practice. In the post-implementation period, the denominator will be determined by tracking patient-level decision-support fires. In the pre-implementation period, the denominator will be determined by applying the decision-support algorithm to retrospective data in monthly increments to identify patients who would have been eligible.
Measured: 4-month time series analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start19 Jul 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Four-month time series trial
- Masking
- None (open label)
- Enrolment
- 2,803 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404999
- Sponsor's protocol ID
- STU 052015-029
- Status last verified
- May 2020
- First submitted
- 12 Jan 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are being obtained under a MU agreement/legal contract
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Clinical-Decision Support to Improve Hypertension Care Among Overweight Children in Primary Care
- ClinicalTrials.gov ID
- NCT03404999
- Acronym / sponsor ID
- STU 052015-029
- Conditions
- Hypertension, Blood Pressure, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,803 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. If successful, this approach can be used to address other lifestyle-related and complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used nationwide.
The investigators have developed a new, electronic health-record (EHR)-based tool that is designed to help pediatricians:
- IDENTIFY AND DOCUMENT
- when a child's blood pressure is elevated, and
- whether it has been elevated before--including number of prior elevations to document the correct diagnosis (for example, elevated blood pressure, vs. hypertension stage 1, vs. hypertension stage 2), THEN
- ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including:
- laboratories and studies per 2017 updated guidelines
- follow-up interval in primary care
- referral to nephrology, when indicated, and
- patient education on diet/lifestyle modification.
The investigators are working on improving this system further with addition of orders for:
- referral for sleep-apnea testing and treatment, when indicated, and
- blood-pressure medications (for example, initiation, titration, or addition of agents depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for pregnancy)
Detailed description
The investigators' data suggest that (1) addressing obesity-related comorbidities (in combination with high BMI/overweight/obesity) and more frequent follow-up are associated with weight-status improvement in overweight (OW) children, (2) that parents rank checking for weight-related health problems as the #1 most important recommended weight-management clinical practice, but that (3) comorbidities are infrequently addressed. Thus, to improve weight status, interventions are needed to improve comorbidity identification, evaluation, and management in primary care. Because the investigators' data suggest that identification of high blood pressure is particularly poor, and that identifying blood-pressure elevations in young children at three separate encounters is complex, they are using existing underutilized data to automate addressing high blood pressure/hypertension in an electronic health record system (EPIC-based), and, if successful, applying the method to other obesity-related comorbidities in primary care.
OF NOTE: in developing and pilot-testing this decision support tool, providers wanted access to it for patients without overweight/obesity. Thus, although the trial was borne out of work in weight-management research, the initial trial will focus on all children irrespective of weight status.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Four-month time series trial
| Arm | Type | Receives |
|---|---|---|
| clinical decision support activated | Experimental | Other: clinical decision supportTWO MED ASSIST ALERTS 1. Enter height (when missing) 2. Repeat BP (when high) ONE PROVIDER ALERT 1. BP high \& prior BP/BP%s 2. Defines elev. BP, HTN stage 1-2 with button to enter diagnosis 3. Link to tailored ordersets TAILORED ORDERSETS 1. Elevated BP 1. Button to schedule f-up <6 m 2. Button for diet/lifestyle counseling/check-out instructions 2. HTN stage 1 1. Buttons to order labs/studies pre-checked for stage 1 recs 2. Button for nephrology referral 3. Button to schedule f-up in 1-2 wk/<1 m 4. Button for diet/lifestyle counseling/check-out instructions 3. HTN stage 2 1. Buttons to order labs/studies for stage 2 2. Button for nephrology referral (pre-checked) 3. Button to f-up 1 wk 4. Button for diet/lifestyle counseling/check-out instruction |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Measured systolic or diastolic blood pressure >=90th % for age/sex, or
- >=120 mmHg systolic or >=80 mmHg diastolic (whichever is lower)
Key exclusion criteria (3 listed)
- Lack of electronic health record
- Diagnosis/visit for high blood pressure or hypertension in past 2 years
- Taking anti-hypertensive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical decision supportDecision support system (see description of hypertension decision support system alerts and order sets for details) | Other | clinical decision support activated |
Primary outcome
High blood pressure addressed
Time frame: 4-month time series analysis
Proportion of patients with high blood pressure addressed post decision-support implementation (vs. pre-), defined as proportion of patients with elevated blood pressures or higher who have one or more diagnosis or orders placed to diagnose, evaluate, or manage hypertension. We will compare the slope of the post- vs. pre-implementation periods to examine change in monthly rate of HTN eval/management (indicated elements ordered/patients eligible) related to decision support that are in excess of secular trends in clinical practice. In the post-implementation period, the denominator will be determined by tracking patient-level decision-support fires. In the pre-implementation period, the denominator will be determined by applying the decision-support algorithm to retrospective data in monthly increments to identify patients who would have been eligible.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: No. Data are being obtained under a MU agreement/legal contract
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical decision support in people with Hypertension and Blood Pressure, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High blood pressure addressed (time frame: 4-month time series analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.